A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents
Launched by ASTRAZENECA · Sep 28, 2011
Trial Information
Current as of June 13, 2025
Completed
Keywords
ClinConnect Summary
A 26 week, randomized, double-blind, parallel-group, active controlled, multicenter, multinational safety study evaluating the risk of serious asthma-related events during treatment with Symbicort®, a fixed combination of inhaled corticosteroid (ICS) (budesonide) and a long acting β2-agonist (LABA) (formoterol) as compared to treatment with ICS (budesonide) alone in adult and adolescent (≥12 years of age) patients with asthma.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Provision of signed informed consent/ paediatric assent (if applicable) prior to any study specific procedures including medication withdrawal
- • Male or Female, ≥12 years of age
- • Documented clinical diagnosis of asthma for at least 1 year prior to Visit 2
- * Patient must have history of at least 1 asthma exacerbation including one of the following:
- • requiring treatment with systemic corticosteroids
- • an asthma-related hospitalization between 4 weeks and 12 months prior to randomization
- • Current Asthma Therapy: Patients must be appropriately using one of the treatments for asthma listed in the protocol combined with achieving certain results when recording an Asthma Control Questionnaire
- Exclusion Criteria:
- • Patient has a history of life-threatening asthma. Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support.
- • Patient has required treatment with systemic corticosteroids (tablets, suspensions or injectable) for any reason within 4 weeks prior to Visit 2
- • Patient has an ongoing exacerbation, defined as a worsening of asthma that requires treatment with systemic corticosteroids (tablets, suspension, or injectable)
- • An asthma exacerbation within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization or more than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization
- • Patient has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of Visit 2 that, in the investigator's opinion, will interfere with the patient's lung function
- • Patient must not meet unstable asthma severity criteria as listed in the protocol
- • Peak expiratory flow must not be below 50% o predicted normal
- • Pregnancy, breast-feeding or planned pregnancy during the study
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Birmingham, Alabama, United States
Huntsville, Alabama, United States
Anchorage, Alaska, United States
Mesa, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Anaheim, California, United States
Bellflower, California, United States
Fountain Valley, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Riverside, California, United States
San Jose, California, United States
Stockton, California, United States
Walnut Creek, California, United States
Denver, Colorado, United States
Norwalk, Connecticut, United States
Waterbury, Connecticut, United States
Clearwater, Florida, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Leesburg, Florida, United States
Miami, Florida, United States
Ocoee, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Savannah, Georgia, United States
Springfield, Illinois, United States
Evansville, Indiana, United States
Michigan City, Indiana, United States
Ames, Iowa, United States
Lexington, Kentucky, United States
Lafayette, Louisiana, United States
Lake Charles, Louisiana, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Kalamazoo, Michigan, United States
Port Huron, Michigan, United States
Southfield, Michigan, United States
Ypsilanti, Michigan, United States
Duluth, Minnesota, United States
Jackson, Mississippi, United States
Chesterfield, Missouri, United States
St Louis, Missouri, United States
Grand Island, Nebraska, United States
Bronx, New York, United States
Great Neck, New York, United States
Rochester, New York, United States
Rockville Centre, New York, United States
Charlotte, North Carolina, United States
Greensboro, North Carolina, United States
Greenville, North Carolina, United States
Salisbury, North Carolina, United States
Wilmington, North Carolina, United States
Winston Salem, North Carolina, United States
Fargo, North Dakota, United States
Oklahoma City, Oklahoma, United States
Bend, Oregon, United States
Bryn Mawr, Pennsylvania, United States
Phoenixville, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Warwick, Rhode Island, United States
Charleston, South Carolina, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Baytown, Texas, United States
Dallas, Texas, United States
Plano, Texas, United States
Waco, Texas, United States
Danville, Virginia, United States
Seattle, Washington, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Milwaukee, Wisconsin, United States
Ostrava, , Czech Republic
Plzen, , Czech Republic
Houston, Texas, United States
Berlin, , Germany
Buenos Aires, , Argentina
Hamburg, , Germany
Cape Town, , South Africa
Durban, , South Africa
Johannesburg, , South Africa
Pretoria, , South Africa
Fort Smith, Arkansas, United States
Poway, California, United States
Fort Lauderdale, Florida, United States
Decatur, Georgia, United States
Abington, Pennsylvania, United States
Doylestown, Pennsylvania, United States
Virginia Beach, Virginia, United States
Ciudad De Buenos Aires, , Argentina
Mar Del Plata, , Argentina
Porto Alegre, , Brazil
Sao Paulo, , Brazil
Pleven, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Santiago, , Chile
Perpignan, , France
Leipzig, , Germany
Seoul, , Korea, Republic Of
Guadalajara, , Mexico
Manila, , Philippines
Quezon City, , Philippines
Kraków, , Poland
Szczecin, , Poland
Moscow, , Russian Federation
Nitra, , Slovakia
St Petersburg, , Russian Federation
Quilmes, , Argentina
San Miguel De Tucuman, , Argentina
Napoli, , Italy
Roma, , Italy
Monterrey, , Mexico
Morelia, , Mexico
Cali, , Colombia
Santa Ana, California, United States
Belfast, , United Kingdom
Praha 10, , Czech Republic
Brasov, , Romania
Bucharest, , Romania
Craiova, , Romania
Ekaterinburg, , Russian Federation
Saint Petersburg, , Russian Federation
Leicester, , United Kingdom
St. Petersburg, , Russian Federation
Kiev, , Ukraine
Bydgoszcz, , Poland
Bangalore, , India
New Delhi, , India
Trivandrum, , India
Hialeah, Florida, United States
Georgetown, Texas, United States
Praha 8, , Czech Republic
Genova, , Italy
Padova, , Italy
Saratov, , Russian Federation
Escondido, California, United States
Edina, Minnesota, United States
Cary, North Carolina, United States
Mexico, , Mexico
Lima, , Peru
Iasi, , Romania
Bratislava, , Slovakia
Kosice, , Slovakia
Donetsk, , Ukraine
Kharkiv, , Ukraine
Kazan, , Russian Federation
Vinnitsa, , Ukraine
Stara Zagora, , Bulgaria
Bologna, , Italy
Dnipropetrovsk, , Ukraine
Poltava, , Ukraine
Uzhgorod, , Ukraine
Goiania, , Brazil
Santo André, , Brazil
Benevento, , Italy
Cluj Napoca, , Romania
Yaroslavl, , Russian Federation
Zilina, , Slovakia
Ivano Frankivsk, , Ukraine
Deland, Florida, United States
Mckinney, Texas, United States
Bucuresti, , Romania
Pasadena, California, United States
Marburg, , Germany
Glendale, Arizona, United States
Miami Beach, Florida, United States
Pembroke Pines, Florida, United States
Killeen, Texas, United States
Beroun, , Czech Republic
Rokycany, , Czech Republic
Gorzów Wlkp, , Poland
Karpacz, , Poland
Ostrów Wielkopolski, , Poland
Tarnów, , Poland
Turek, , Poland
Umkomaas, , South Africa
Conyers, Georgia, United States
Council Bluffs, Iowa, United States
Greer, South Carolina, United States
Deva, , Romania
Bangkok, , Thailand
Angers, , France
Palermo, , Italy
Coventry, , United Kingdom
Stockport, , United Kingdom
Bardejov, , Slovakia
Blackpool, , United Kingdom
Córdoba, , Argentina
Zapopan, , Mexico
Ruse, , Bulgaria
Bath, , United Kingdom
Anderson, Indiana, United States
Owensboro, Kentucky, United States
San Antonio, Texas, United States
Alhambra, California, United States
Encinitas, California, United States
Northridge, California, United States
Tustin, California, United States
Altamonte Springs, Florida, United States
Catanzaro, , Italy
Roseville, California, United States
Pharr, Texas, United States
Sugar Land, Texas, United States
Caguas, , Puerto Rico
San Juan, , Puerto Rico
Novosibirsk, , Russian Federation
Praha 4, , Czech Republic
Crawley, , United Kingdom
Trowbridge, , United Kingdom
Watford, , United Kingdom
Coimbatore, , India
Iloilo City, , Philippines
Khon Kaen, , Thailand
Ho Chi Minh, , Vietnam
Durango, , Mexico
Botucatu, , Brazil
Tg. Mures, , Romania
Tierce, , France
Pasig City, , Philippines
Hanoi, , Vietnam
Hyderabad, , India
Chippenham, , United Kingdom
México, , Mexico
Quillota, , Chile
New York, New York, United States
Cincinnati, Ohio, United States
Presov, , Slovakia
Ferrara, , Italy
Omaha, Nebraska, United States
Kansas City, Missouri, United States
Costa Mesa, California, United States
Summerville, South Carolina, United States
Constanta, , Romania
Mangalore, , India
Strzelce Opolskie, , Poland
Westbury, , United Kingdom
Litomerice, , Czech Republic
Liptovsky Mikulas, , Slovakia
Seongnam Si, , Korea, Republic Of
Pittsburgh, Pennsylvania, United States
Vina Del Mar, , Chile
Leamington Spa, , United Kingdom
Kutna Hora, , Czech Republic
Ruzomberok, , Slovakia
San Diego, California, United States
Wrocław, , Poland
Saint Petersburg, , Russian Federation
Sterling Heights, Michigan, United States
Opalocka, Florida, United States
Spring, Texas, United States
Buena Park, California, United States
Vicksburg, Mississippi, United States
Verona, New Jersey, United States
Sugarland, Texas, United States
Gilbert, Arizona, United States
Ciudad De Panama, , Panama
Palmdale, California, United States
South Burlington, Vermont, United States
Meridan, Idaho, United States
Calicut, , India
Canterbury, , United Kingdom
Razgrad, , Bulgaria
Penza, , Russian Federation
Toa Baja, , Puerto Rico
Breclav, , Czech Republic
Thornton, Colorado, United States
Wyomissing, Pennsylvania, United States
Bellevue, Nebraska, United States
Lanham, Maryland, United States
Biloxi, Mississippi, United States
Volgograd, , Russian Federation
Białystok, , Poland
Fort Worth, Texas, United States
Komarno, , Slovakia
Zvolen, , Slovakia
Vidin, , Bulgaria
Krnov, , Czech Republic
Dunajska Streda, , Slovakia
Sevlievo, , Bulgaria
Vladikavkaz, , Russian Federation
Zaporozye, , Ukraine
La Crosse, Wisconsin, United States
Hayden Lake, Idaho, United States
Mysore, , India
Nagpur, , India
Stpetersburg, , Russian Federation
Verulam, , South Africa
Bogotá, , Colombia
Lipa City, , Philippines
Odesa, , Ukraine
Gotse Delchev, , Bulgaria
Razlog, , Bulgaria
Manizales, , Colombia
Kissimmee, Florida, United States
Juiz De Fora, , Brazil
Villahermosa, , Mexico
Watertown, Massachusetts, United States
Goa, , India
Cheonan Si, , Korea, Republic Of
Monte Grande, , Argentina
Ranelagh, , Argentina
Santiago De Querétaro, , Mexico
Yekaterinburg, , Russian Federation
Arvin, California, United States
Lehigh Acres, Florida, United States
Lynn Haven, Florida, United States
Royal Palm Beach, Florida, United States
Calhoun, Georgia, United States
Kenilworth, Illinois, United States
Fort Mitchell, Kentucky, United States
Madison Hgts, Michigan, United States
Bridgeton, Missouri, United States
Hopewell Jct, New York, United States
Miamishburg, Ohio, United States
Stow, Ohio, United States
Greeneville, South Carolina, United States
Indian Land, South Carolina, United States
Layton, Utah, United States
Vienna, Virginia, United States
San Miguel De Tucumán, , Argentina
Barueri, , Brazil
Kozloduy, , Bulgaria
Petrich, , Bulgaria
Sandanski, , Bulgaria
Ansan Si, , Korea, Republic Of
Cheongju Si, , Korea, Republic Of
Jinju Si, , Korea, Republic Of
Monterey, , Mexico
Cusco, , Peru
Chęciny, , Poland
Skarżysko Kamienna, , Poland
Urszulin, , Poland
Bragadiru, , Romania
Skalica, , Slovakia
Boksburg North, , South Africa
Breyton, , South Africa
Lenasia, , South Africa
Lyttleton, , South Africa
Hat Yai, , Thailand
Muang,, , Thailand
Naimuang, , Thailand
Patients applied
Trial Officials
Carin Jorup
Study Director
AstraZeneca Pepparedsleden 1, 431 83 Mölndal
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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